Chapter VI
GENETICALLY MODIFIED ORGANISMS ELIGIBLE FOR USE AS FOOD OR ANIMAL FEED
Section I. GENETICALLY MODIFIED ORGANISMS ELIGIBLE FOR USE AS FOOD
Article 27. Conditions for grant of a written certification of genetically modified organisms* eligibility for use as food
To be granted a written certification of eligibility for use as food, genetically modified organisms must satisfy either of the following conditions:
1. The dossier of application for a written certification of their eligibility for use as food has been appraised by the Genetically Modified Food Safety Council, which concludes that such genetically modified organisms have no uncontrollable risks to human health.
2. They have been permitted by at least five (5) developed countries for use as food and no risk has been seen in these countries.
Article 28. Competence, order and procedures for grant or revocation of a written certification of genetically modified organisms' eligibility for use as food
1. The Ministry of Health may grant and revoke a written certification of genetically modified organisms' eligibility for use as food.
2. An applicant for a written certification of genetically modified organisms' eligibility for use as food shall submit three (3) dossier sets to the Ministry of Health. Such a dossier comprises:
a/ An application for a written certification of genetically modified organisms' eligibility for use as food, made according to the form specified by the Ministry of Health;
b/ A report on assessment of risks of genetically modified organisms to human health, made according to Appendix V to this Decree;
c/ For-genetically modified organisms specified in Clause 2, Article 27 of this Decree, documents evidencing that they have been permitted for use as food in five (5) developed countries are required.
3. Within 7 working days after receiving a dossier, the Ministry of Health shall notify its acceptance of the valid dossier to the applicant or request the applicant to supplement and complete the dossier under regulations. The time for dossier supplementation and completion will not be included in the time for dossier appraisal.
4. Within 180 days after receiving a valid dossier of application for a written certification of genetically modified organisms' eligibility for use as food, the Ministry of Health shall set up a genetically modified organisms safety council to appraise the dossier. For genetically modified organisms specified in Clause 2, Article 27 of this Decree, the maximum duration for grant of. or refusal to grant, such a written certification is 60 days.
5. After receiving a valid dossier, the Ministry of Health shall publish information on the report on assessment of risks of genetically modified organisms to human health on its website for public comment. Public comments shall be summarized and reported to the Genetically Modified Food Safety Council. The maximum duration for collecting public comments is 30 days after information is published.
6. Within 30 days after obtaining appraisal results, the Minister of Health shall examine them and grant a written certification of genetically modified organisms' eligibility for use as food. In case of refusal, it shall issue a notice clearly stating the reason to the applicant.
7. Applicants for a written certification of genetically modified organisms' eligibility for use as food shall pay a charge for dossier appraisal. The Ministry of Finance shall assume the prime responsibility for, and coordinate with the Ministry of Health in, specifying rates, management and use of the charge for dossier appraisal.
8. The Ministry of Health shall specify the order and procedures for granting a written certification of genetically modified organisms eligibility for use as food.
9. The Genetically Modified Food Safety Council shall advise the Minister of Health on whether to grant a written certification of genetically modified organisms' eligibility for use as food. This Council shall be composed of representatives of the Ministries of Industry and Trade: Science and Technology: Agriculture and Rural Development; Natural Resources and Environment; and Health, and some experts.
The Minister of Health shall decide to set up. and define the functions, tasks and operation mechanism of. the Genetically Modified Food Safety Council.
Article 29. Revocation of a written certification of genetically modified organisms" eligibility for use as food
1. A written certification of genetically-modified organisms eligibility for use as food will be revoked in the following cases:
a/ There is a new scientific proof of the risks of genetically modified organisms that have been granted such certification:
b/ Organizations or individuals intentionally provide untruthful information which is decisive to the grant of such certification;
c/ There is a proof that the Genetically Modified Food .Safety Council's conclusions lack scientific grounds.
2. The Ministry of Health shall decide to revoke a written certification of genetically modified organisms' eligibility for use as food and issue a written notice to the organization or individual having such certification and publish the revocation in the mass media.
3. From the date of issuance of decisions revoking a written certification of genetically modified organisms* eligibility for use as food, organizations or individuals are disallowed to use genetically modified organisms and products thereof as food.
Article 30. Contents of a written certification of genetically modified organisms' eligibility for use as food
1. A written certification of genetically modified organisms' eligibility for use as food contains:
a/ Names of genetically modified organisms: scientific names, common names, gene transmission events and the sole identification numbers, if any;
b/ Detailed information on the organization or individual that is granted the certification;
c/ Specific requirements to ensure safety during the use of genetically modified organisms.
2. The Ministry of Health shall stipulate the form of a written certification of genetically modified organisms' eligibility for use us food.
Article 31. List of genetically modified organisms eligible to be granted a written certification of eligibility for use as food
1. The Ministry of Health shall make a list of genetically modified organisms eligible to be granted a written certification of eligibility for use as food and publish this list on its website.
2. Within 10 days after granting or revoking a written certification of genetically modified organisms' eligibility for use as food, the Ministry of Health shall add or delete the names of genetically modified organisms to or from such list.
Section 2. GENETICALLY MODIFIED ORGANISMS ELIGIBLE FOR USE AS ANIMAL FEED
Article 32. Conditions for grant of a written certification of genetically modified organisms' eligibility for use as animal feed
1. To be granted a written certification of eligibility for use as animal feed, genetically modified organisms must satisfy either of the following conditions:
a/ The dossiers of application for a written certification of their eligibility for use as animal feed have been appraised by the Genetically Modified Livestock Feed Safety Council, which concludes that such genetically modified organisms have no uncontrollable risks to domestic animals.
b/ They have been permitted by at least five (5) developed countries for use as animal feed and no risk has been seen in these countries.
2- Genetically modified organisms that are granted a written certification of eligibility for use as animal feed may be used as animal feed.
Article 33. Competence, order and procedures for grant or revocation of a written certification of genetically modified organisms' eligibility for use as animal feed
1. The Ministry of Agriculture and Rural Development may grant and revoke a written certification of genetically modified organisms* eligibility for use as animal feed.
2. An applicant for a written certification of genetically modified organisms" eligibility for use as animal feed shall submit three (3) dossier sets to the Ministry of Agriculture and Rural Development. Such a dossier comprises:
a/ An application for such certification, made according to the form specified by the Ministry of Agriculture and Rural Development;
b/ A report on assessment of risks of genetically modified organisms to domestic animals, made according to Appendix VI to this Decree;
c/ For genetically modified organisms specified at Point b. Clause 1, Article 32 of this Decree, documents evidencing that they have been permitted for use as animal feed in five (5) developed countries are required.
3. Within 7 working days after receiving a dossier, the Ministry of Agriculture and Rural Development shall notify its acceptance of the valid dossier to the applicant or request the applicant to supplement and complete the dossier under regulations. The time for dossier supplementation and completion will not be included in the time for dossier appraisal.
4. Within 180 days after receiving a valid dossier of application for a written certification of genetically modified organisms* eligibility for use as animal feed, the Ministry of Agriculture and Rural Development shall set up a genetically modified animal feed safety council to appraise the dossier. For genetically modified organisms specified at Point b. Clause 1. Article 32 of this Decree, the maximum duration for grant of such certification is 60 days.
5. After receiving a valid dossier, the Ministry of Agriculture and Rural Development shall publish information on the report on assessment of risks of genetically modified organisms to domestic animals on its website for public comment. Public comments shall be summarized and reported to the Genetically Modified Animal Feed Council Safety. The maximum duration for collecting public comments is 30 days after information is published.
6. Within 30 days after obtaining appraisal results, the Minister of Agriculture and Rural Development shall examine them and grant a written certification of genetically modified organisms' eligibility for use as animal feed. In case of refusal, it shall issue a notice clearly stating the reason to the applicant.
7. Applicants for a written certification of genetically modified organisms' eligibility for use as animal feed shall pay a charge for dossier appraisal. The Ministry of Finance shall assume the prime responsibility for. and coordinate with the Ministry of Agriculture and Rural Development in. specifying rates, management and use of the charge for dossier appraisal.
8. The Ministry of Agriculture and Rural Development shall specify the order and procedures for granting a written certification of genetically modified organisms' eligibility for use as animal feed.
9. The Genetically Modified Animal Feed Safety Council shall advise the Minister of Agriculture and Rural Development whether to grant a written certification of genetically modified organisms eligibility for use as animal feed. This Council is composed of representatives of the Ministries of Industry and Trade; Science and Technology; Agriculture and Rural Development: Natural Resources and Environment; and Health, and some experts.
The Minister of Agriculture and Rural Development shall decide to set up. and define the functions, tasks and operation mechanism of. the Genetically Modified Animal Feed Safety Council.
Article 34. Revocation of a written certification of genetically modified organisms" eligibility for use as animal feed
1. A written certification of genetically modified organisms' eligibility for use as animal feed will be revoked in the following cases:
a/ There is a new scientific proof of the risks of genetically modified organisms that have been granted such certification:
b/ Organizations or individuals intentionally provide untruthful information which is decisive to the grant of such certification:
c/ There is a proof that the Genetically Modified Animal Feed Safety Council's conclusions lack scientific grounds.
2. The Ministry of Agriculture and Rural Development shall decide to revoke a written certification of genetically modified organisms' eligibility for use as animal feed and issue a written notice to organizations and individuals having such certification and publish the revocation in the mass media.
3. From the date of issuance of decisions revoking a written certification of genetically modified organisms" eligibility for use-as animal feed, organizations and individuals are disallowed to use genetically modified organisms and products thereof as animal feed.
Article 35. Contents of a written certification of genetically modified organisms* eligibility for use as animal feed
1. A written certification of genetically modified organisms" eligibility for use as animal feed contains:
a/ Names of genetically modified organisms: scientific names, common names. gene transmission events and the sole identification numbers, if any:
b/ Detailed information on the organization or individual that is granted the certification;
c/ Specific requirements to ensure safety during the use of genetically modified organisms.
2. The Ministry of Agriculture and Rural Development shall stipulate the form of a written certification of genetically modified organisms' eligibility for use as animal feed.
Article 36. List of genetically modified organisms eligible to be granted a written certification of eligibility for use as animal feed
1. The Ministry of Agriculture and Rural Development shall make a list of genetically modified organisms eligible to be granted a written certification of eligibility for use as animal feed and publish this list on its website.
2. Within 10 days after granting or revoking a written certification of genetically modified organisms' eligibility for use as animal feed, the Ministry of Agriculture and Rural Development shall add or delete the names of genetically modified organisms to or from such list.
Tìm kiếm
Nghị định 69/2010/NĐ-CP (Bản Word)
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